KARL STORZ ICG Imaging System, Image1S Camera Control Unit
510(k) K233333
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK233333 | Date21 Nov 2023 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
- 510(k) Number
- FDA Product Code
- OWN
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Karl Storz ICG Imaging System is a confocal optical imaging device designed for near-infrared fluorescence imaging. It enables real-time visualization of indocyanine green (ICG) fluorescence, facilitating precise intraoperative assessment in surgical procedures.
This system is supplied as a reusable medical device and is intended for use in controlled clinical environments such as operating rooms. It is classified as a Class II device under FDA regulations and has received FDA 510(k) clearance and MDR authorization. The Image1S Camera Control Unit operates in conjunction with compatible imaging probes and is not MRI-safe.
Other devices from Karl Storz SE & CO. KG
Questions
AI-generated answers, 18 Sep 2026
What types of surgical procedures can the Karl Storz ICG Imaging System be used for, and how does it assist during surgery?
The Karl Storz ICG Imaging System is designed for near-infrared fluorescence imaging of indocyanine green (ICG), enabling real-time visualization during surgical procedures. While it is not intended for any specific clinical indication, its primary use is in controlled environments like operating rooms to enhance precision by highlighting ICG fluorescence. This aids in identifying vascular structures, assessing tissue perfusion, or guiding surgical margins—particularly useful in fields like gastroenterology and urology, as referenced in the advisory committee records.
Is the Image1S Camera Control Unit reusable, and if so, what maintenance or care is required?
Yes, the Image1S Camera Control Unit is supplied as a reusable medical device. Since it is intended for controlled clinical environments like operating rooms, proper cleaning, sterilization, and maintenance procedures must be followed as per manufacturer guidelines to ensure functionality and safety. The reusable nature aligns with its classification as a Class II device, requiring adherence to rigorous operational protocols.
What regulatory pathways has the Karl Storz ICG Imaging System followed, and what does this mean for clinicians or buyers?
The system has received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming it meets regulatory standards for safety and performance. The clearance type is traditional, and the device is classified as substantially equivalent to existing products. This means clinicians can rely on its established safety profile, while buyers can trust its compliance with both U.S. and EU regulatory frameworks, ensuring seamless integration into clinical workflows.
Are there specific models or variations of the ICG Imaging System, and how do they differ?
The system includes the Image1S Camera Control Unit, which operates in conjunction with compatible imaging probes. While the provided data lists multiple registration numbers (FEI numbers) associated with different probe variations, these are administrative identifiers rather than distinct clinical models. The core functionality—near-infrared fluorescence imaging for ICG—remains consistent across these probes, but compatibility and technical specifications may vary by probe type, as outlined in the manufacturer’s documentation.